BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3884901 · Received June 19, 2014

    Report

    Report Number
    2134265-2014-03639
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE UNIT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. THE UNIT MET SPECIFICATIONS FOR THE MOTORDRIVE UNIT-5 QC FUNCTIONAL TEST AND SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN OVERNIGHT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF NOT CONFIRMED WAS ASSIGNED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR: 2134265-2014-03802; 2134265-2014-03803. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. A 240V ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN UNSPECIFIED BSC IMAGING CATHETER IN A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PERFORM PULLBACK BUT AUTOMATIC PULLBACK FAILED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR: 2134265-2014-03802; 2134265-2014-03803. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. A 240V ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN UNSPECIFIED BSC IMAGING CATHETER IN A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PERFORM PULLBACK BUT AUTOMATIC PULLBACK FAILED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360087 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB240CART0 0000006186

    Patients

    Seq Age Sex Outcome Treatment
    1